The Opportunity:

An important role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments within the Chanelle Group.

KEY RESPONSIBILITIES:

• Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning.
• Manage the validation requirements of Chanelle and third party suppliers and CMO’s.
• Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation).
• To maintain and take responsibility for the cleaning validation strategy at Chanelle.
• To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU.
• Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications.
• Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and    R&D teams.
• Establishing, implementing and directing validation and revalidation activities.
• Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
• Reviewing and managing Change Control Forms for Validation implications.
• Reviewing and managing Non-Conformance’s for Validation Implications.
• Updating existing quality documentation related to validation activities.
• Identifying training requirements in support of validation.
• Ensuring completion of validation protocols.
• Carry out Internal Audits as required.
• Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
• Maintaining validation documentation system.
• Required to Lead cross functional teams providing knowledge in resolution in any technical issues.
• Assisting in the preparation and hosting of associated regulatory and customer audits.

QUALIFICATIONS & COMPETENCIES:

• Minimum Bachelor of Science or Engineering.
• 4-5 years’ experience in a pharmaceutical environment.
• Good computer skills with Word, Excel and any other statistical programs.
• Knowledge of Process and Cleaning Validation.
• Ability to conduct internal audits.
• Ability to perform in external audits.

WORK ENVIRONMENT: (eg. Office, Production)